Viking Therapeutics
26 named things its latest annual report says its results depend on, each in the company's own words. 17 of them are also named by other companies we've read.
Suppliers
Corden Pharma Colorado, Inc. (CordenPharma)
depends on · annual commitment to supply 100 million autoinjectors and an additional 100 million vial and syringe productsnamed as a riskMoreover, if we encounter delays or difficulties in the scale-up of our manufacturing processes or our relationships with CordenPharma, this could delay the submission of product candidates for regulatory approval and also delay the market introduction and subsequent sales of any of our product candidates that receive regulatory approval, which would have a material adverse effect on our business, financial condition and results of operations.Risk factors (Item 1A)
Contract research organizations (CROs)
depends onnamed as a riskWe have relied upon and plan to continue to rely upon third-party CROs, medical institutions, clinical investigators and contract laboratories to conduct studies and monitor and manage data for our licensed ongoing preclinical and clinical programs.Risk factors (Item 1A)
Also named by GILD
Partners and platforms
Ligand Pharmaceuticals Incorporated
depends on · up to an aggregate of approximately $1.54 billion in development, regulatory and sales milestonesnamed as a riskOur business is substantially dependent upon technology licensed from Ligand.Risk factors (Item 1A)
Competitors
Eli Lilly and Company
competes withnamed as a riskVK2735, if approved, will compete against therapies that are already approved and marketed for obesity, including Semaglutide (Wegovy®) and liraglutide (Saxenda®) from Novo Nordisk A/S, and tirzepatide (Zepbound®) from Eli Lilly and Company.Risk factors (Item 1A)
Amgen Inc.
competes withnamed as a riskWe are also aware of several programs targeting obesity that are in the late development stage that will compete against VK2735, if approved, including CagriSema from Novo Nordisk A/S, orforglipron and retatrutide from Eli Lilly and Company, survodutide (BI 456906) from Boehringer Ingelheim International GmbH, and MariTide from Amgen Inc., and ribupatide from Kailera Therapeutics.Risk factors (Item 1A)
Novo Nordisk A/S
competes withnamed as a riskVK2735, if approved, will compete against therapies that are already approved and marketed for obesity, including Semaglutide (Wegovy®) and liraglutide (Saxenda®) from Novo Nordisk A/S, and tirzepatide (Zepbound®) from Eli Lilly and Company.Risk factors (Item 1A)
Madrigal Pharmaceuticals, Inc.
competes withnamed as a riskResmetirom (Rezdiffra™), another agonist of the thyroid hormone receptor beta, or TRß, from Madrigal Pharmaceuticals, Inc., is the only therapy currently approved in the U.S. for the treatment of NASH/MASH.Risk factors (Item 1A)
Boehringer Ingelheim International GmbH
competes withnamed as a riskWe are also aware of several programs targeting obesity that are in the late development stage that will compete against VK2735, if approved, including CagriSema from Novo Nordisk A/S, orforglipron and retatrutide from Eli Lilly and Company, survodutide (BI 456906) from Boehringer Ingelheim International GmbH, and MariTide from Amgen Inc., and ribupatide from Kailera Therapeutics.Risk factors (Item 1A)
bluebird bio, Inc.
competes withnamed as a riskMore recently, gene therapy has been shown to be effective in CALD, and elivaldogene autotemcel from bluebird bio, Inc., has received accelerated approval by the FDA (to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active CALD), and approval by the European Commission (for patients less than 18 years of age with early CALD without a matched sibling donor).Business (Item 1)
Places
China
operates innamed as a riskAs such, the lack of strong patent and other intellectual property protection in China may significantly increase our vulnerability regarding unauthorized disclosure or use of our intellectual property and undermine our competitive position.Risk factors (Item 1A)
Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more
Australia
operates innamed as a riskOne of our subsidiaries is located in Ireland and another is located in Australia and we may further expand our international operations.Risk factors (Item 1A)
Also named by AJG, ARWR, AXP, BF/B, BTU, CL, CSGP, CVX and 15 more
Ireland
operates innamed as a riskOne of our subsidiaries is located in Ireland and another is located in Australia and we may further expand our international operations.Risk factors (Item 1A)
Also named by AAPL, ACN, ADI, AGX, BEN, CDNS, CELH, COR and 13 more
Hazards
Commodities and inputs
Raw materials for drug manufacturing
depends onnamed as a riskThere are a limited number of suppliers for raw materials that we use to manufacture our drugs, and there may be a need to identify alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our drug candidates for our clinical trials, and, if approved, ultimately for commercial sale.Risk factors (Item 1A)
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskIf funding for the FDA is reduced, if the FDA workforce is reduced, or if the current government shutdown continues, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
European Medicines Agency (EMA)
subject tonamed as a riskOur drug candidates are subject to extensive regulation under the FDA, EMA or comparable foreign authorities, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals to commercialize our drug candidates.Risk factors (Item 1A)
Laws and programs
EU General Data Protection Regulation (GDPR)
subject to · up to 4% of global revenues or €20 millionnamed as a riskThe GDPR increases our obligations with respect to clinical trials conducted in the EEA by expanding the definition of personal data to include coded data and requiring changes to informed consent practices and more detailed notices for clinical trial subjects and investigators.Risk factors (Item 1A)
Also named by ACN, ADSK, AIG, ALK, AMG, ANET, APG, AXON and 61 more
Medicare
earns fromnamed as a riskIf we are unable to show a significant benefit relative to existing generic drugs, Medicare, Medicaid and private payors may not be willing to provide reimbursement for our drugs, which would significantly reduce the likelihood of our products gaining market acceptance.Risk factors (Item 1A)
Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more
Inflation Reduction Act (IRA)
subject tonamed as a riskThe current and future effects of the IRA on our business is not yet known.Business (Item 1)
Also named by AEE, AMGN, ARWR, BIIB, BKNG, BMY, CAH, CI and 26 more
Medicare Part D
subject tonamed as a riskOur business, financial condition and results of operations could be materially adversely affected if Part D prescription drug plans were to limit access to, or deny or limit reimbursement of, our drug candidates or other potential products.Risk factors (Item 1A)
Also named by ABBV, AMGN, BMY, CI, CNC, CVS, ELV, INCY and 5 more
Orphan Drug Act
subject tonamed as a riskWhile we received orphan drug designation from the FDA for VK0214 for the treatment X-ALD in December 2016, we, or any future collaborators, may not be granted orphan drug designations for our product candidates in the U.S. or in other jurisdictions.Risk factors (Item 1A)
Hatch-Waxman Amendments
subject tonamed as a riskIf we do not obtain additional protection under the Hatch-Waxman Amendments and similar foreign legislation extending the terms of our licensed patents and any future patents we may own, our business, financial condition and results of operations may be materially and adversely affected.Risk factors (Item 1A)
U.S. tariffs on imported pharmaceutical products
subject tonamed as a riskA trade war or other governmental action related to tariffs or international trade agreements or policies has the potential to disrupt our research activities, affect our suppliers, increase the cost of materials purchased to manufacture our products, impact our ability to sell our products outside the United States or to sell our products outside the United States at competitive prices and/or to affect the United States or global economy or certain sectors thereof and, thus, could adversely impact our business and financial condition.Risk factors (Item 1A)